Effect of Bhadradi Kashaya as Oral Administration and as Basti Administration in the Management of Sthula Pramehi(Diabesity) and Obesity
Phase 2
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complicationsHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/02/050014
- Lead Sponsor
- All India Institute Of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. BMI - >25-35
2.FBS â?? >126-300mg/dl
PPBS - >200-380mg/dl
3.HbA1c- >6.5-12
(Patient having classical symptom of sthula and prameha as per ayurvedic
text).
4.Waist-hip ratio-
Male - > 1
Female >0.86
5. Waist circumference-
Male - > 102 cm
Female- > 80cm
6.HbA1c- <5.7( for sthula individual)
Exclusion Criteria
1. Patients unfit for Basti Karma.
2. Chronicity: More than 5yrs.
3. Severe systemic diseases like- Pulmonary tuberculosis. Gestational
diabetes and malignancy
4. Patients with T2 DM exceeding the following plasma glucose limits-
a) Fasting plasma glucose values of >= 300mg/dL
b) RBS,PPBS>= 380mg/dL
5. Juvenile Diabetes
6. Insulin dependent Diabetes mellitus
7. Individuals with co-morbidity like HTN (sthula individual)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Bhadradi Kashaya when administered Orally and as Basti in the management of Sthula Pramehi (Diabesity)based on clinical parameters(sign and symptoms of Pameha), Biomarker and stool metabolites(SCFAâ??s). <br/ ><br>â?¢ To evaluate change in body weight and BMI, WHR in the patients of Sthula Pramehi (Diabesity) as well as healthy Obese. <br/ ><br>Timepoint: 0th,19th,34th day <br/ ><br>
- Secondary Outcome Measures
Name Time Method To see changes in Gut microbiome diversity <br/ ><br> To evaluate the quality of life. <br/ ><br>Timepoint: 0th,19th,34th day